Device for the connection in a sterile environment of a peritoneal catheter to a dialysis liquid drain or feed tube

ABSTRACT

A device for alternate sterile connection of a peritoneal catheter, permanently attached to a patient, to a drain tube and to a feed tube for a dialysis liquid, which apparatus comprises a shell in which a first chamber, a second chamber and a connection channel between said chambers are formed and filled with a disinfecting liquid. The chambers include respective couplings for releasable and repeatable coupling the peritoneal catheter and the drain or feed tube with the chambers in conditions of full immersion in the disinfecting liquid. This arrangement makes a tight sterile connection between said catheter and, alternately, said drain and feed tubes via said connection channel.

The present invention relates to a device for the connection in asterile environment of a peritoneal catheter to a tube for draining orfeeding dialysis liquid.

Among the peritoneal dialysis techniques for the treatment of uraemicpatients, continuous ambulatorial peritoneal dialysis (CAPD) is of greatimportance.

This technique, devised in 1975, consists in connecting a plasticcontainer with approximately two liters of a dialysis liquid (a solutionwith added glucose normally isosmotic with plasma) to a peritonealcatheter permanently attached to the patient, by means of a shortplastic tube with appropriate connectors at its two ends. Afterconnection, the dialysis liquid fills the peritoneal cavity, where theblood which surrounds the peritoneal membrane exchanges the substancespresent in the aqueous phase and transfers the uraemic toxins to thedialysis liquid. After an appropriate space of time, the peritonealcavity is emptied by connecting a drain tube to the peritoneal catheter.

For effective depuration of the patient, the aforementioned procedurehas to be repeated daily at least four times during the day. Thisexposes the patient to the risk that, during the manoeuvres forpermanent catheter connection to the drain tube first, in order to emptythe peritoneal cavity of the liquid which is not full of toxins, and tothe bag subsequently, so as to fill the peritoneal cavity with cleandialysis liquid, pathogenic agents may be introduced into the peritonealcavity, causing the onset of bacterial peritonitis.

In view of the state of the art described, the object of the presentinvention is that of providing a device which enables the connection ina sterile environment of the peritoneal catheter to the drain tube firstand to the feed tube for dialysis liquid subsequently, in order toreduce to a minimum the possibility during these operations ofpathogenic agents being introduced into the peritoneal cavity.

In accordance with the present invention, this object is achieved thanksto a device for the connection in a sterile environment of a peritonealcatheter, permanently attached to a patient, to a drain tube or feedtube for a dialysis liquid, characterised in that it comprises a shellwherein a first chamber and a second chamber are formed, which chambersare suitable for being filled with a disinfecting liquid, and aconnection channel which connects the two chambers one to the other.Respective coupling means are also provided in each chamber forcoupling, in conditions of immersion in the disinfecting liquid, to saidperitoneal catheter and said drain tube or said feed tube respectively,to form via said connection channel a sealed connection between saidcatheter and said drain tube or said feed tube.

Thanks to the device according to the present invention, the peritonealcatheter may be connected either to the drain tube or to the feed tubein a totally sterile environment, in that coupling of the peritonealcatheter, of the drain tube and of the feed tube to the coupling meansprovided in the chambers filled with disinfecting liquid takes place inconditions of immersion in the disinfecting liquid itself.

Preferably, said shell is also provided with an additional pair ofchambers, also connected one to the other and to the chambers of thefirst pair in order to be also filled with said disinfecting liquid,each chamber of said second pair being suitable for holding, inconditions of immersion in the disinfecting liquid, a cap for closingsaid peritoneal catheter and said feed tube. In this way, the operationsof removing the closure caps normally provided at the ends of theperitoneal catheter and of the feed tube may be performed in a fullysterile environment.

These and other features and advantages of the present invention will bemade clearer from the following detailed description of two of itsembodiments, illustrated by way of non-limiting examples in theaccompanying drawings, in which:

FIG. 1 is a view sectioned along a vertical plane of a device accordingto a first embodiment of the present invention;

FIG. 2 is a plan view of the device of FIG. 1;

FIGS 3-6 show four phases of an operation of connecting a peritonealcatheter to a bag containing a dialysis liquid;

FIG. 7 is a sectioned view of a connector with which the ends of theperitoneal catheter and of a feed tube are normally provided;

FIG. 8 is a sectioned view of a cap suitable for being coupled to theconnector of FIG. 7 to close said peritoneal catheter and said feedtube;

FIG. 9 is a perspective view of a device according to a secondembodiment of the present invention;

FIG. 10 is a plan view of the device of FIG. 9;

FIG. 11 is a section along line XI--XI of FIG. 10;

FIG. 12 is a section along line XII--XII of FIG. 10;

FIG. 13 is a section along line XIII--XIII of FIG. 10.

Referring to FIGS. 1 and 2, they show in a section along a verticalplane a first embodiment of a device for the connection in a sterileenvironment of a peritoneal catheter, permanently attached to a patient,to a tube for draining the dialysis liquid present in the peritonealcavity of the patient, or to a tube for feeding clean dialysis liquid,normally contained in a bag.

The device substantially consists of a shell 1 inside whereof fourchambers 2, 3, 4 and 5 are formed, substantially conical in shape. Onthe base of the chambers 2 and 5 two connectors 6 are stably housed,each provided with a central through hole, complementary to connectors31 (of the so-called "luer-lok" type shown in FIG. 7) normally providedat the ends of the peritoneal catheter and of the tube for feedingdialysis liquid. In the example shown, since it is assumed that theconnectors 31 placed at the ends of the catheter and of the feed tubeare male connectors, the connectors 6 provided on the base of thechambers 2 and 5 are female connectors, with tubular appendage andexternal threading. However, should the connectors at the ends of thecatheter and of the feed tube be female connectors, the connectors 6provided on the base of the chambers 2 and 5 should be male connectors.

On the base of the shell 1, a connection channel 7 connects the chambers2 and 5 via the through holes of the connectors 6.

The central chambers 3 and 4, which in this first embodiment have asmaller depth than the chambers 2 and 5, lead on the base to a secondconnection channel 8 which also flows into the chamber 2 near the baseof the latter. Moreover, in the baffle 9 which separates the chambers 2and 3 and in the baffle 10 which separates the chambers 4 and 5 twofurther connection channels 11 and 12 are formed which connect thechambers 2 and 3 and the chambers 4 and 5 respectively.

All the chambers are however connected one to the other.

The two central chambers 3 and 4 are also provided, near their base,with respective seats 30 suitable for holding closure caps 32 (of thetype shown in FIG. 8) which can be screwed onto the connectors 31provided at the ends of the peritoneal catheter and of the feed tube toclose the latter tight.

For the use of the device described above, it is first of all necessaryto fill the chambers with a disinfecting liquid, typically 100%"Amuchina" or the like. Since the four chambers 2-5 are all connectedone to the other, any chamber can be chosen in which to pour thedisinfectant. Filling proceeds until the level of disinfectant reached areference notch. This starting conditions is illustrated in FIG. 1;however chambers 2-5, as also all the connection channels 7, 8, 11 and12, are filled with the disinfecting liquid.

In the following description it will be assumed that use is made of aperitoneal dialysis device of the type described in a contemporaryItalian patent application in the name of the same applicant, a devicewhich comprises a bag 12 (FIGS. 3-6) containing the dialysis liquid andfrom which two flexible tubes 13 and 14 extend and which are connectedto a portion 15 of the same bag 12 which can be separated hydraulically,for example by means of a clip 16, from the remaining of the bag 12.This dialysis device, which constituted an improvement of the knownconnection system referred to as "Y-set", is merely mentioned here byway of an example, in that the connection device of the presentinvention can also be used with other devices, for example the Y-set.

The first operation which the patient has to perform consists ofdraining the dialysis liquid present in the peritoneal cavity. For thispurpose the bag portion 15 is isolated hydraulically from the remainingof the bag 12 by means of the clip 16, one (no. 14) of the two tubeswhich extend from the bag 12, after the respective closure cap 32 hasbeen removed therefrom, is connected to a drain recipient 17, and theend of the other tube 13, still provided with the respective closure cap32, is inserted by a downward movement in the chamber 3 (an operationfacilitated by the conical shape of the chambers, which avoids problemsof alignment) so that the cap 32 engages in the seat 30 (FIG. 3).

By acting on a handle 33 of the male connector 31 (FIG. 7) placed at theend of the tube 13, the patient makes it rotate by approximately half aturn in relations to the cap 32, which is maintained fixed in its seat30, until the connector 31 is unscrewed from the cap 31. Then theconnector 31 is inserted in the chamber 2 and is screwed onto the femaleconnector 6 housed on the base of the latter (FIG. 4). It should benoted that the operations of unscrewing the cap 32 and screwing of themale connector 31 on the female connector 6 occur in conditions ofimmersion in the disinfecting liquid, and hence in a sterileenvironment, without the need for the patient to touch the open end ofthe connector 31 or to put the latter down in order to perform otheroperations. Neither is it necessary for the patient to wet his or herfingers with disinfectant, in that the handle 33 is sufficientlyextended to project in relation to the surface of the disinfectingliquid. Once the connection has been made, both the cap 32 and theconnector 31 remain immersed in the disinfecting liquid.

Thus the device 1 is connected to a drain conduit, consisting of thetube 13, the bag portion 15 isolated from the remaining of the bag 12and the tube 14.

At this point the patient must connect his or her peritoneal catheter tothe device 1. This is carried out in a wholly similar manner to what hasbeen described: the patient inserts the end of the catheter 18 (FIG. 5),still provided with the respective closure cap 32, in the chamber 4, sothat the cap 32 is engaged in the respective seat 30 (FIG. 5).

By acting on the handle 33 of the male connector 31, the patientunscrews the latter from the cap 32 (maintained fixed in the seat 30),then inserts the connector 31 in the chamber 5 and screws it onto thefemale connector 6 provided on the base of the latter (FIG. 6).

In this way the catheter 18 is connected to the tube 13 via theconnection channel 7.

By opening a tap 19 normally provided on the catheter 18 (typicallyconsisting of a so-called "roller"), the operation of draining thedialysis liquid present in the peritoneal cavity of the patient begins.During this operation, the dialysis liquid to be drained empties theconnection channel 7 of the disinfecting liquid.

After the draining phase, the tube 14 of the bag 12 is closed near itsend connected to the bag itself, for example by means of another clip,and the bag portion 15 is reconnected to the remaining of the bag 12(which contains the dialysis liquid) by removing the clip 16. Thedialysis liquid present in the bag 12 is thus fed, via the tube 13, thechannel 7 and the catheter 18, to the peritoneal cavity of the patient.

At the end of the feed phase, the patient closes the tap 19, unscrewsthe connector 31 of the catheter 18 from the connector 6 on the base ofthe chamber 5, removes it from the chamber 5, inserts it in the chamber4, screwing it on the relevant closure cap 32, and finally removes theconnector 31, with the relevant cap 32, from the chamber 4. Then, in awholly similar manner, the patient disconnects the connector 31 of thetube 13 from the connector 6 on the base of the chamber 2, inserts it inthe chamber 3, screwing it on the relevant closure cap 32, and removeseverything from the chamber 3.

FIGS. 9-13 show a second embodiment of the connection device accordingto the present invention.

In this embodiment, the shell 1 of the connection device has asubstantially cylindrical shape, with a widened base 50. The fourchambers 2, 3, 4 and 5 are arranged in a circumferential series in theshell 1 and all have the same depth. The chambers are connected two bytwo thanks to connection channels 51. Moreover, the chambers 2 and 5 areconnected at their base thanks to a connection channel 52 diametrical tothe shell 1 and open at its two ends to facilitate the operation ofemptying and washing of the connection device at the end of the dialysisoperations. Two plugs 53 are also provided for closing the openings ofthe connection channel 52 during the dialysis operations.

As indicated by the foregoing description, the connection device of thepresent invention, involving operations which are performed in sequenceand not simultaneously, requires the use of only one hand.

Another advantage of the device of the present invention lies in thefact that it can be reused for a theoretically infinite number ofexchanges of dialysis liquid. It thus avoids the use of expensive safetydevices related to the bag assembly, which after use are thrown awaytogether with the latter.

I claim:
 1. A device for alternate sterile connection of a drain tubeand feed tube to one end of a peritoneal catheter which catheter isadapted to be permanently attached to a patient at the other end fortreating the patient with dialysis liquid, the device comprising:a shellin which a first chamber, a second chamber and a connection channelbetween said chambers are formed and filled with a disinfecting liquid,wherein said chambers include respective couplings for releasable andrepeatable alternative coupling of said peritoneal catheter to saiddrain tube and to said feed tube with said chambers in conditions offull immersion of the couplings in the disinfecting liquid whereby atight sterile connection between said catheter and, alternately, saiddrain and feed tubes occurs during treatment of the patient so that thedevice is reusable for successive feeding and draining procedures.
 2. Adevice according to claim 1 wherein the couplings selectively open andclose connections between the peritoneal catheter and the drain tube andthe peritoneal catheter and feed tube via operators which are outside ofthe disinfecting liquid.
 3. A device according to claim 2 wherein theoperators are handle portions of the couplings which extend out of thedisinfecting liquid.
 4. A device according to claim 1, wherein thechambers each have a base or wherein the connection channel is connectedto the bases of the two chambers.
 5. A device according to claim 4,wherein said connection channel opens outside of the device at an openend, the end being provided with a removable plug for closing the openend of the connection channel.
 6. A device according to claim 5, whichfurther includes a third chamber and a fourth chamber connected one tothe other and to said first and second chambers so as to be filled bysaid disinfecting liquid, said third and fourth chambers each comprisinga respective seat suitable for housing, in conditions of immersion inthe disinfectant, a closure cap which can be coupled to saidcomplementary connector normally provided at the end of the catheter andof the feed tube to close the catheter and feed tube tight.
 7. A deviceaccording to claim 6, wherein said first, second, third and fourthchambers are arranged in a circumferential series and are connected oneto the other and two by two via respective connection channels.
 8. Adevice according to claim 4, wherein said couplings each comprise aninternally hollow connector which can be coupled to a complementaryconnector provided at the end of said peritoneal catheter and of saidfeed and drain tubes.
 9. A device according to claim 8, wherein theconnectors provided in the first and second chambers are both femaleconnectors which can be coupled to male connectors provided at the endof said peritoneal catheter and of said feed and drain tubes.
 10. Adevice according to claim 8, wherein the connectors provided in thefirst and second chamber are both male connectors which can be coupledto female connectors provided at the end of said peritoneal catheter andof said feed and drain tubes.
 11. A device according to claim 10,wherein said third and fourth chambers are connected from bases thereofto a second connection channel which in turn is connected to one of saidfirst and second chambers.
 12. A device according to claim 11, whereineach of said third and fourth chambers leads into a respective one ofsaid first and second chambers via a respective connection channelformed in a respective baffle.